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A Post-Authorisation Safety Study Patient Registry of Patients With Neuroblastoma Being Treated With Dinutuximab Beta

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04253015
Recruitment Status : Active, not recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
United BioSource, LLC
Information provided by (Responsible Party):
EusaPharma (UK) Limited

Brief Summary:
This is a non-interventional, multi-national, observational, prospective patient registry to further evaluate the effectiveness and safety of dinutuximab beta - a monoclonal immunoglobulin G 1 (IgG1) antibody, to obtain information on survival, pain severity and incidence of neuro-toxicity, visual impairment, capillary leak syndrome, cardiovascular events, hypersensitivity reactions and long-term safety.

Condition or disease Intervention/treatment
Neuroblastoma Other: Data-collection

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 125 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: A Post-Authorisation Safety Study Patient Registry of Patients With High-risk Neuroblastoma Being Treated With the Monoclonal Antibody Dinutuximab Beta
Actual Study Start Date : September 30, 2019
Estimated Primary Completion Date : October 30, 2031
Estimated Study Completion Date : January 15, 2032

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Neuroblastoma
Drug Information available for: Dinutuximab


Intervention Details:
  • Other: Data-collection
    Data will be collected on dose, total cumulative amount of dinutuximab beta per course, dose interruptions, dose discontinuations, prophylactic treatment, use of all concomitant analgesia, assessments of pain, and occurrence of neurotoxicity, visual impairment, capillary leak syndrome, cardiovascular events and hypersensitivity reactions and other AEs.


Primary Outcome Measures :
  1. Assessment of the severity of pain experienced by participants during treatment with dinutuximab beta [ Time Frame: First dose of dinutuximab beta to the end of the last 35 day course of the 5th cycle of treatment (each cycle is 35 days) ]
    Assessment of pain severity experienced by participants during the period of first dose of dinutuximab beta to the end of last 35 day course of 5th cycle of treatment

  2. Number of participants using analgesics during treatment with dinutuximab beta [ Time Frame: First dose of dinutuximab beta to the end of the last 35 day course of the 5th cycle of treatment (each cycle is 35 days) ]
    Use of analgesics during the period of first dose of dinutuximab beta to end of last 35 day course of 5th cycle of treatment

  3. Incidence of neurotoxicity, visual impairment, capillary leak syndrome, cardiovascular events and hypersensitivity reactions [ Time Frame: First dose of dinutuximab beta to the end of the last 35 day course of the 5th cycle of treatment (each cycle is 35 days) ]
    Incidence of neurotoxicity, visual impairment, capillary leak syndrome, cardiovascular events and hypersensitivity reactions up to the end of the last 35 day course of 5th cycle of treatment

  4. Number of participants experiencing serious adverse events (SAEs) and adverse drug reactions (ADRs) during treatment with dinutuximab beta [ Time Frame: First dose of dinutuximab beta to the end of the last 35 day course of the 5th cycle of treatment (each cycle is 35 days) ]
    Number of participants experiencing serious adverse events (SAEs) and adverse drug reactions (ADRs) following the end of the last 35 day course of 5th cycle of treatment


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: First dose of dinutuximab beta to the end of the last 35 day course of the 5th cycle of treatment (each cycle is 35 days) ]
    Overall Survival (OS) following the end of the last 35 day course of 5th cycle of treatment

  2. Progression free survival (PFS) [ Time Frame: First dose of dinutuximab beta to the end of the last 35 day course of the 5th cycle of treatment (each cycle is 35 days) ]
    Progression free survival (PFS) following the end of the last 35 day course of 5th cycle of treatment

  3. Event Free Survival (EFS) [ Time Frame: First dose of dinutuximab beta to the end of the last 35 day course of the 5th cycle of treatment (each cycle is 35 days) ]
    Event Free Survival (EFS) following the end of the last 35 day course of 5th cycle of treatment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with high-risk neuroblastoma who are starting treatment with dinutuximab beta in the standard clinical practice setting or participating in a clinical trial where dinutuximab beta is provided according to the indication as per the country/regional marketing authorisation, provide consent/assent and are willing to be followed up for up to 10 years. Centers who treat neuroblastoma patients with dinutuximab beta will be invited to participate in the registry. This includes networks such as the Society of Paediatric Oncology for the Treatment of Neuroblastoma (SIOPEN) in Europe.
Criteria

Inclusion Criteria:

Patients meeting the following criteria will be considered for inclusion into the registry:

  • Patients diagnosed with high-risk neuroblastoma and starting treatment with commercially available dinutuximab beta OR
  • Patients diagnosed with high-risk neuroblastoma and starting treatment with dinutuximab beta in a clinical trial where dinutuximab beta is provided according to the country/regional marketing authorisation AND
  • Appropriate consent/assent has been obtained for participation in the registry with a willingness to be followed up for up to 10 years.

Exclusion Criteria:

Patient will not be eligible for inclusion if the following criterion applies:

  • Patients commencing dinutuximab beta within a clinical trial where the product is being provided outside of the country/regional marketing authorisation OR
  • Appropriate consent/assent has not been obtained for participation in the registry or patient/legal representative is not willing for the patient be followed up for up to 10 years.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04253015


Locations
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Austria
St. Anna Kinderkrebsforschung
Wien,, Vienna, Austria, 1090
France
Centre Oscar Lambret
Lille, France, 59000
Hôpital de la Timone, Hôpital des Enfants
Marseille, France, 13385
Institut Curie
Paris, France, 75005
Institut Gustave Roussy
Villejuif, France, 94805
Germany
Charité Berlin
Berlin, Germany, 13353
Universitätsmedizin Greifswald
Greifswald, Germany, 17475
Uniklinik Köln
Köln, Germany, 50924
Italy
IRCCS Istituto Giannina Gaslini
Genova, Italy, 16147
Poland
Uniwersytecki Szpital Dziecięcy
Kraków, Poland, 30-663
Spain
Hospital Universitario y Politecnico La Fe Avenida Fernando Abril Martorell
Valencia, Spain, 46026
United Kingdom
Birmingham Children's Hospital
Birmingham, United Kingdom, B4 6NH
University Hospital Southampton
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
EusaPharma (UK) Limited
United BioSource, LLC
Investigators
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Study Director: Jonathan Morgan, Dr EUSA Pharma (UK) Limited
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Responsible Party: EusaPharma (UK) Limited
ClinicalTrials.gov Identifier: NCT04253015    
Other Study ID Numbers: EUSA DB 0001
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by EusaPharma (UK) Limited:
Tumour
Brain tumour
Paediatrics
Additional relevant MeSH terms:
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Neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue